POS0289 A CONCEPTUAL FRAMEWORK OF THE COURSE AND TIMEFRAME OF PATIENT-REPORTED ADVERSE DRUG REACTIONS OF BIOLOGICS IN IMMUNE-MEDIATED INFLAMMATORY DISEASES
Authors: J. Van Lint, N. Jessurun, S. Tas, H. Vonkeman, F. Hoentjen, M. Van Doorn, M. Nurmohamed, B. Van den Bemt
Journal: Annals of the Rheumatic Diseases (2022)

Background Patients with immune-mediated inflammatory diseases (IMIDs) need chronic drug treatment, including biologics, which may cause adverse drug reactions (ADRs). Information about ADRs is usually restricted to the type of ADRs that may occur with drug use. Common patterns in the course and timeframe of ADRs are often not described while this information may provide valuable insights for patients and healthcare professionals. Objectives To identify common and corresponding items with thematic analysis in the described course of ADRs of biologics reported by patients with IMIDs. Methods We used qualitative data from the Dutch Biologic Monitor (DBM) to assess the patient’s descriptions of the course of ADRs they experienced. IMID patients were asked to fill out a bimonthly questionnaire on experienced ADRs they attributed to the use of a biologic [1, 2]. Inclusion criteria were: patients reporting an ADR and elaboration on the course of the ADR in an open-ended text field. Answers of the patients on the course of the experienced ADR were analysed by two pharmacovigilance assessors with a thematic analysis with an inductive approach to develop a conceptual framework which was visualised using an Ishikawa diagram. Results From 1382 consecutive participants, 730 patients reported 2035 ADRs. Six themes with multiple subthemes were identified from patient descriptions on the course of the ADRs they experienced (Figure 1). Four themes included descriptive items of the course of ADRs: the moment or period of ADR occurrence (e.g. a specific moment of the day or in a specific season), the frequency of an ADR episode (e.g. once, sometimes, often, always or recurring with or without specified frequency), the duration of an ADR episode (e.g. specified duration, constant, variable increasing or decreasing duration) or an association in time with the administration moment (e.g. before, during or after biologic administration or a specific time to onset in relation to the moment of biologic administration). Two themes included factors influencing the course of ADRs: triggering factors for ADR occurrence or aggravation (e.g. administration method, social, physical or mental status, nutrition, external factors, (co)medication or daily activities) and improving factors (e.g. administration method, treatment, physical or mental status, nutrition or selfcare). Figure 1. A conceptual framework of descriptions of the course and timeframe of adverse drug reactions reported by patients using a biologic for immune-mediated inflammatory diseases Conclusion We identified six themes in patient-reported descriptions of the course of ADRs of biologics. These themes provide information about ADRs on a broader level than the currently available information on nature and frequency. Information about ADRs enriched with details on the course and timeframe of ADRs may support healthcare professionals in improving clinical practice by discussing ADRs with patients and finding practical solutions in dealing with ADRs. This will ultimately lead to more optimised medical treatment. References [1]Kosse LJ, Jessurun NT, Hebing RCF, Huiskes VJB, Spijkers KM, van den Bemt BJF, et al. Patients with inflammatory rheumatic diseases: quality of self-reported medical information in a prospective cohort event monitoring system. Rheumatology (Oxford ). 2020;59(6):1253-61. [2]van Lint JA, Jessurun NT, Hebing RCF, Hoentjen F, Tas SW, Vonkeman HE, et al. Patient-Reported Burden of Adverse Drug Reactions Attributed to Biologics Used for Immune-Mediated Inflammatory Diseases. Drug Saf . 2020;43(9):917-925. Disclosure of Interests Jette van Lint: None declared, Naomi Jessurun: None declared, Sander Tas Consultant of: Gebro, GSK, AbbVie, Galvani, Arthrogen/MeiraGTx, Galapagos, Grant/research support from: Pfizer, GSK, Celgene, BMS, Sanofi, AstraZeneca, Harald Vonkeman Speakers bureau: Amgen, BMS, Celgene, Galapagos, GSK, Janssen-Cilag, Lilly, Novartis, Pfizer, Roche, Sanofi-Genzyme, UCB, Grant/research support from: Abbvie, Sanofi-Genzyme, Frank Hoentjen Speakers bureau: served on advisory boards or as speaker for Abbvie, Janssen-Cilag, MSD, Takeda, Celltrion, Teva, Sandoz and Dr Falk, Consultant of: Celgene, Grant/research support from: Funding (Grants/Honoraria): Dr Falk, Janssen-Cilag, Abbvie, Takeda, Martijn van Doorn Speakers bureau: Janssen, LEO Pharma, Pfizer, Novartis, Paid instructor for: LEO Pharma, Consultant of: AbbVie, Janssen, LEO Pharma, Pfizer, Celgene, Novartis, TEVA, MSD, Sanofi, AstraZeneca, Grant/research support from: Novartis, Janssen, Michael Nurmohamed Speakers bureau: Abbvie, Janssen, Celgene, Consultant of: Abbvie, Grant/research support from: Abbvie, Amgen, Pfizer, Galapagos, BMS, Bart van den Bemt Speakers bureau: UCB, Pfizer, Sanofi-Aventis, Galapagos, Amgen en Eli Lilly